Package deal for SOCRA CCRP Certification Exam With 100% Correct Answers 2023

Contract Research Organization - Correct Answer-A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. When a short form is used for informed consent the witness must sign the short form or ...

Timeline of Historical Events - Correct Answer-Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report - Correct Answer-respect for persons, beneficence, justice Application of Respect for Persons - Correct Answer-informed consent (autono...

Nuremberg Code (1947) - Correct Answer-A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. The Nuremberg Code - 10 points - Correct Answer-1. voluntary 2. necessary for results 3. logical ...

April 30 1996 - Correct Answer-ICH GCP Development Date Quality - Correct Answer-ICH Q Efficacy - Correct Answer-ICH E Safety - Correct Answer-ICH S Multidisciplinary - Correct Answer-ICH M guidance for industry, consolidated guideance - Correct Answer-ICH E 6 Clinical Safety Data Management D...

45 CFR 46 Subpart A - Correct Answer-"Basic HHS Policy for Protection of Human Research Subjects": (46.100) Requirements for 1) assuring compliance by research institutions, 2) researchers' obtaining and documenting informed consent, 3) Institutional Review Board (IRB) membership, function, o...

What is an orphan drug program? - Correct Answer-FDA program that provides development of drugs for rare diseases Nuremburg Code - Correct Answer-set of standards proclaimed following the trial of Nazi doctors in 1947 Kefauver-Harris Amendment - Correct Answer-Amendment to Food Drug and Cosmetic...

Laws - Correct Answer-passed by national legislative bodies; establish authority of national regulatory body Regulations - Correct Answer-Passed by regulatory authorities; controls how medical products are investigated and approved; have effect of law guidance - Correct Answer-"current thinking...

Which of the following is a disclosure of financial interests form? - Correct Answer-FDA Form 3455 Which of the following is a certification of financial interest form? - Correct Answer-FDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the fo...

Biometrics - Correct Answer-A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) Closed System - Correct Answer-...

Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? - Correct Answer-False. The general provisions for electeonic signature criteria apply to records that are i. Created, modified, maintained, archived, retrieved, or transmitted, in electr...